ctDNA in Cutaneous Squamous Cell Carcinoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts Eye and Ear Infirmary
Study ID
NCT06875609
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blood and Tissue Collection — DIAGNOSTIC_TEST
    Blood samples, and tissue samples will be collected from the participants, and used to determine whether circulating tumor DNA (ctDNA) testing can help monitor treatment in patients with CSCC, and to determine how ctDNA levels change in patients.

Study Details

The purpose of this study is to test the potential for a liquid biopsy assay to detect residual disease after surgery in patients with cutaneous squamous cell carcinoma as well as the potential for this assay to monitor response to immunotherapy treatment.

Key Dates

Start date
Mar 24, 2025
Status verified
Mar 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Post-Operative Cohort
    Cutaneous Squamous Cell Carcinoma cancer patients treated with surgery.
  • Arm: Neoadjuvant Cohort
    Cutaneous Squamous Cell Carcinoma patients treated with Neoadjuvant immunotherapy.
  • Arm: Definitive Immunotherapy Cohort
    Cutaneous Squamous Cell Carcinoma patients treated with definitive immunotherapy.

Primary Outcome Measure

2-year recurrence-free survival (RFS) in patients with detectable vs no detectable ctDNA after surgery [ Time Frame: 24 Months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts Eye and EarBostonMassachusetts02114
Michael Cheung, MSc, CCRP
617-573-6060
Sophia Shalhout, PhD (PRINCIPAL_INVESTIGATOR)

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